Clinical Trial Manager II – Site Management

This is a fully remote position, open to applicants in Poland.

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables focusing on patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manages site interactions from post-activation through to site closeout, which may involve patient recruitment, investigator payments, and other related activities.

• May be tasked with identifying critical data and processes, assessing protocol execution risks, and implementing risk mitigation strategies associated with the completion of the Risk Assessment and Categorization Tool (RACT).

• Reviews the study’s scope of work, budget, and protocol content to ensure that the clinical project team (CRAs/CeMs) is informed of contractual obligations and parameters.

• Leverages prior clinical experience, operational data, metrics, and reports to identify risks related to clinical trial management deliverables.

• Escalates any risks to clinical trial management deliverables (timeline, quality, and budget) to the project manager, along with any activities or requests that fall outside the contracted scope.

• Utilizes strategic thinking and problem-solving capabilities to propose and implement risk mitigation strategies.

• Participates in and presents at key meetings such as the Kick Off Meeting.

• Acts as a point of escalation for communications with investigator site staff and may need to engage with principal investigators or other site staff members via phone or in person.

• Collaborates with functional leaders such as Study Start Up, Patient Recruitment, and Data Management to synchronize delivery handoffs and meet anticipated study milestones, including site activation targets, enrollment goals, and database lock timelines.

• Responsible for creating and maintaining clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensures that CTMS, dashboards, and other systems are prepared and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Verifies that access and audit trail reviews are conducted as required.

• Coordinates initial and ongoing training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and study timelines.

• Oversees resource allocation for CRAs and Central Monitors, site assignments, and the conduct of study team members, while identifying risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project, maintaining visibility of progress through approved systems and/or tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to supervise site and patient activities, study team conduct, and ensure data is updated to reflect timely execution of all operational aspects (required visits/calls, duration, frequency) according to plan.

• Understands the monitoring strategy necessary for the study and, when required, participates in developing the study risk assessment plan.

• Holds accountability for their assigned clinical team members’ understanding, ongoing compliance, and delivery in line with the established monitoring strategy, CMP/SMP, and risk plans.

• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence) to ensure they accurately reflect site management activities and conduct, and appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures these deliverables are provided according to company and/or sponsor specifications, including stipulated delivery deadlines.

• Engages with clients and other functional departments concerning clinical monitoring, central monitoring, and site management activities and deliverables.

• Updates clients, project management, and leadership on the status of clinical deliverables and risks as per departmental or study agreements.

• Offers solutions to challenges in protocol execution and site management.

• Demonstrates comprehension of the roles of other functions in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.

• Supports Inspection Readiness for the clinical trial management scope.

• Supervises CRAs and Central Monitors assigned to the study and routinely evaluates study-specific process and training compliance, CMP compliance, and identifies emerging risks.

• Develops and supports the execution of corrective action plans at both the site and study levels.

• Aids and completes activities to meet data cut and lock deadlines.

• Provides feedback to line managers regarding staff performance, highlighting strengths and areas for development.

• May be assigned to larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams towards achieving project milestones.

• Demonstrated capacity for working in an international environment.

• Established expertise in site management and monitoring (clinical or central).

• Preferred experience with risk-based monitoring.

• Shows understanding of clinical trial management financial principles and budget management.

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must possess strong computer skills.

• Excellent communication, presentation, and interpersonal skills with project teams and sites.

• Strong conflict resolution capabilities.

• Demonstrated ability to apply problem-solving techniques to tackle complex issues and utilize a risk management approach to identify and mitigate potential threats to the successful execution of a clinical research project.

• Exhibits critical thinking to ascertain the cause and appropriate solution in addressing issues.

• Moderate travel may be necessary, approximately 20%.

🏝️ Benefits

• We are dedicated to developing our employees through career advancement and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.